Example 2. Business Biotics Group wide ranging capabilities
- Business Biotics Group was commissioned to strategically guide a client to upgrade an existing non licensed facility to a GMP licensed facility for the aseptic manufacture of Phase I/II clinical trial product.
- An initial audit of the existing facility was conducted and a number of key strategic recommendations were presented.
- The recommendations were commensurate with the client’s aspirations to contain cost and provide viable solutions to achieve the strategic goal of GMP compliance for the aseptic manufacture of Phase I/II clinical trial product.
- The situation was challenging and required expertise and experience as the facility was multifunctional and contained a number of different operational scenarios, including PC2 containment, fermentation suites, laboratories and cleanrooms.
- These areas were under the same roof, shared services and were physically interconnected.
- Business Biotics Group provided the solutions and assigned the order of project priorities.
- The solutions included the design of a new facility air pressure differential regime, personnel and product flows, highly purified water system and pilot scale dispensing machine, autoclave and Grade A environment.
- Our experience provided the client a cost effective strategy of achieving GMP compliance for the aseptic manufacture of Phase I/II clinical trial product.
Example 3. Business Biotics Group engineering and manufacturing capabilities
- Business Biotics Group was commissioned to strategically guide a client to upgrade an existing licensed facility to facilitate FDA GMP compliance for the aseptic manufacture of veterinary medicines.
- An initial audit of the existing facility was conducted and a number of key strategic recommendations were presented.
- The recommendations were prioritized by risk analysis assessment and further evolved into a Project Plan.
- Business Biotics Group firstly developed a state-of-the-art environmental cleaning procedure involving the selection of disinfectants, cleaning hardware, drafting Standard Operating Procedures and Cleaning Records and the training and accreditation of facility personnel.
- A new environmental monitoring program was then developed which also involved the introduction of new processes and equipment, drafting manufacturing documents and the training and accreditation of staff.
- An appraisal of the HVAC annual certification requirements was completed and changes for FDA compliance recommended.
- A complete review of the dispensing methods for compliance to FDA regulations, resulted in a series of recommendations that entailed room design changes, equipment selection, media fill upgrade and staff accreditation systems.
- These upgrades enabled the client to obtain the primary strategic objective of FDA accreditation which broadened their markets and income potential.
Example 4. Business Biotics Group cutting edge pharmaceutical equipment knowledge.
- The client requirement was to perform a facility upgrade to increase its capacity and flexibility.
- They needed to select and procure several major items of aseptic process equipment including an autoclave, vial washer, static hot air oven and filling machine.
- The client had received several quotations indicating a large variation in price and level of GMP compliance.
- Business Biotics Group was engaged to source appropriate equipment commensurate with the client’s budget and GMP compliance expectations.
- Business Biotics Group successfully provided the client with a full range of equipment from low cost, emerging Asian equipment manufacturers to the high cost European manufacturers.
- Our client was able to select the most appropriate supplier with full knowledge of additional works required and associated risks. The client is confident in the knowledge that their implied and stated quality requirements will be met.
- Business Biotics Group has a large established network of equipment suppliers throughout Australia, Asia, Europe and the United States.
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